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Microvessel Ultrasound Imaging for Chronic Ulcers

N/A

Recruiting

Led By Michael Moynagh, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic wound in the course of diabetic foot ulcers and/or lower extremity venous ulcers with duration of at least 6 weeks and the wound surface not less than 2 sq. cm and not greater than 15 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study

Meets criteria for stalled chronic wound defined as less than 50% reduction in wound size after 30 days of standard of care management

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial uses ultrasounds to look for scarring and monitor wound healing, to see if treatments improve circulation.

Who is the study for?

This trial is for people with chronic ulcers on their lower extremities that have not healed in at least 6 weeks and are between 2-15 sq. cm in size. Participants must have controlled blood sugar, adequate blood flow to the wound, and no active infections or allergies to lidocaine. Smokers and pregnant individuals cannot participate.Check my eligibility

What is being tested?

The study tests a high-resolution microvessel ultrasound imaging system's ability to detect scarring and monitor healing in chronic wounds. It also examines how treatments affect tiny blood vessels and circulation around the wound.See study design

What are the potential side effects?

Potential side effects may include discomfort or minor pain from the ultrasound examination or skin biopsy procedure, as well as possible bruising or bleeding at the biopsy site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a long-lasting wound from diabetes or poor leg circulation that's between 2 and 15 sq. cm large, without any signs of infection.

Select...

My wound has not shrunk by half after 30 days of standard treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Microvessel imaging

Trial Design

1Treatment groups

Experimental Treatment

Group I: Microvessel Ultrasound Imaging for Chronic UlcersExperimental Treatment2 Interventions

Subjects with chronic diabetic ulcers and venous ulcers will undergo wound debridement and treatment as standard of care and receive research microvessel ultrasound examination and two skin biopsies

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Skin Biopsy

2015

Completed Phase 4

~680

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,478 Total Patients Enrolled

Michael Moynagh, MDPrincipal InvestigatorMayo Clinic

Media Library

Microvessel Ultrasound Imaging for Chronic Ulcers Clinical Trial Eligibility Overview. Trial Name: NCT05739149 — N/A

Non-Healing Skin Ulcer Research Study Groups: Microvessel Ultrasound Imaging for Chronic Ulcers

Non-Healing Skin Ulcer Clinical Trial 2023: Microvessel Ultrasound Imaging for Chronic Ulcers Highlights & Side Effects. Trial Name: NCT05739149 — N/A

Microvessel Ultrasound Imaging for Chronic Ulcers 2023 Treatment Timeline for Medical Study. Trial Name: NCT05739149 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining positions available for this research endeavor?

"The trial posted on March 1st 2023 is no longer recruiting patients, as per the latest data available on clinicaltrials.gov from February 13th 2023. Nevertheless, 1072 alternative studies are currently looking for participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers

Michael R. Moynagh 2023. "A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05739149.